EW200 SYSTEM (OXYGEN SATURATION MONITORING SYSTEM) AND PRESEP OXIMETRY CATHETER

K060660 · Edwards Lifesciences, LLC · DXG · Apr 25, 2006 · Cardiovascular

Device Facts

• Record ID: K060660
• Device Name: EW200 SYSTEM (OXYGEN SATURATION MONITORING SYSTEM) AND PRESEP OXIMETRY CATHETER
• Applicant: Edwards Lifesciences, LLC
• Product Code: DXG · Cardiovascular
• Decision Date: Apr 25, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1435
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The EW200 System is indicated for use in patients requiring monitoring of hemodynamic parameters, including oxygen saturation and hemoglobin. The PreSep catheter is indicated for hemodynamic monitoring through oxygen saturation measurement and hemoglobin measurement. Edwards oximetry catheters are indicated for oxygen saturation and hemoglobin measurement.

Device Story

EW200 System is microprocessor-based instrument for continuous monitoring of oxygen saturation (SO2) and hemoglobin (HGB)/hematocrit (HCT) in human blood. System components: console, laptop computer, optical module, and Edwards oximetry catheter. Console emits light transmitted via optical module into blood stream through catheter; reflected light captured and processed to calculate SO2 and HGB. Used in clinical settings for hemodynamic monitoring. Output displayed to healthcare providers to inform clinical decision-making regarding patient hemodynamic status.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by functional testing and electrical safety testing.

Technological Characteristics

Microprocessor-based instrument; fiberoptic oximetry sensing principle; light emission/reflection spectral analysis; system console, laptop, optical module, and catheter form factor; electrical safety testing performed.

Indications for Use

Indicated for patients requiring hemodynamic monitoring of oxygen saturation and hemoglobin levels.

Regulatory Classification

Identification

A single-function, preprogrammed diagnostic computer is a hard-wired computer that calculates a specific physiological or blood-flow parameter based on information obtained from one or more electrodes, transducers, or measuring devices.

Predicate Devices

• Vigilance Continuous Cardiac Output/Oximetry/Continuous End Diastolic Volume (CCO/SvO2/CEDV) Monitor
• 3M CDI Blood Parameter Monitoring System 500
• Central Venous Oximetry Probe Catheter and Probe
• Multi-Med Multi-Lumen Central Venous Catheter
• Edslab Dual Lumen Regional Saturation Oximetry Catheter

Submission Summary (Full Text)

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APR 2 5 2006

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## 510(k) Summary

| Submitter: | Edwards Lifesciences LLC<br>One Edwards Way<br>Irvine, CA 92614-5686 |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Paula A. Torrianni, Director, Regulatory Affairs |
| Date Prepared: | October 28, 2005 |
| Trade name: | EW200 System (Oxygen Saturation and Hemoglobin<br>Monitoring System) |
| | PreSep Oximetry Catheter |
| Classification<br>Name: | Single-Function, Preprogrammed Diagnostic Computer<br>(21 CFR 870.1435) |
| | Catheter, Oximeter, Fiberoptic (21CFR870.1230) |
| Predicate<br>Devices: | Vigilance Continuous Cardiac Output/Oximetry/Continuous<br>End Diastolic Volume (CCO/SvO2/CEDV) Monitor |
| | 3M CDI Blood Parameter Monitoring System 500 |
| | Central Venous Oximetry Probe Catheter and Probe |
| | Multi-Med Multi-Lumen Central Venous Catheter |
| | Edslab Dual Lumen Regional Saturation Oximetry Catheter |
| Device<br>Description: | The EW200 System is a microprocessor-based instrument<br>that, when connected to an Edwards oximetry catheter,<br>provides continuous measurement of oxygen saturation<br>(SO2) and hemoglobin (HGB)/hematocrit (HCT) levels in<br>human blood. The system is comprised of a system<br>console, laptop computer, optical module and Edwards<br>oximetry catheter. The system console emits light that is<br>transmitted into the blood stream through the optical module<br>that connects to the oximetry catheter. The light is reflected<br>back through the catheter to the system console and the<br>spectral data is used to calculate SO2 and HGB. |
| | The PreSep Oximetry catheter is a catheter that is used with<br>Edwards oximetry monitors to measure oxygen saturation<br>and also provides the means for measuring hemoglobin with<br>the EW200 System. |
| | |
| Intended Use: | The EW200 System is indicated for use in patients requiring<br>monitoring of hemodynamic parameters, including oxygen<br>saturation and hemoglobin.<br><br>The PreSep catheter is indicated for hemodynamic<br>monitoring through oxygen saturation measurement and<br>hemoglobin measurement. |
| Comparative<br>Analysis: | The EW200 System and PreSep catheter have been<br>demonstrated to be as safe and effective as the predicate<br>devices for their intended use. |
| Functional/Safety<br>Testing: | The EW200 System and PreSep catheter have successfully<br>undergone functional testing. In addition, the EW200<br>System was also subjected to electrical safety testing.<br>These products have been shown to be equivalent to the<br>predicate devices. |
| Conclusion: | The EW200 System and PreSep catheter are substantially<br>equivalent to the predicate devices. |

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K060660

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Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird with outstretched wings, formed by three curved lines. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the bird. The text is in all capital letters and is evenly spaced around the circle.

MAY 1 5 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Edwards Lifesciences, LLC c/o Ms. Laura Danielson TUV Product Service America 1775 Old Highway 8NW, Suite 104 New Brighton, MN 55112

Re: K060660

Trade/Device Name: EW200 System and PreSep Oximetry Catheter Regulation Number: 21 CFR §870 and 21 CFR §870.1230 Regulation Name: Single-Function, Preprogrammed Diagnostic Computer, and Catheter, Oximeter, Fiberoptic Regulatory Class: Class II (two) Product Code: DXG and DQE Dated: April 25, 2006 Received: April 25, 2006

Dear Ms. Danielson:

This letter corrects our substantially equivalent letter of April 25, 2006.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

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Page 2 - Ms. Laura Danielson

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Bfremman for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Edwards Lifesciences LLC 510(k) Notification for the EW200 System and PreSep Catheter

1666660 510(k) Number (if known):

EW200 System and PreSep Oximetry Catheter Device Name:

Indications for Use:

The EW200 System is indicated for use in patients requiring monitoring of hemodynamic parameters, including oxygen saturation and hemoglobin.

The PreSep Oximetry catheter is indicated for hemodynamic monitoring through oxygen saturation measurement and hemoglobin measurement.

Edwards oximetry catheters are indicated for oxygen saturation and hemoglobin measurement.

Prescription Use ___X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

B. Simmons

n of Cardlovascular Devices 510(k) Number Ko

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